Interview with Audrey Rossow; Preemies, Parental Stunt-Doubles, and ClinOps.

Enjoy this fascinating conversation with Industry expert, Audrey Rossow, as we explore her 25 years in clinical operations and consulting. Audrey shares with us her experiences in the early days of clinical trials, ranging from premature babies (preemies) to epilepsy studies and more.

Editorial note; This interview took place while Audrey was an independent consultant.   She has since joined one of her previous clients as a full time employee and she is the Senior Director of Clinical Operations at Pulmatrix Inc, a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases.

ClinicalBid:Audrey, you've been in this industry 25 years. Tell us a little bit about how you got from where you started to where you are. The good, the bad, and the ugly.
Audrey:My first research experience was as an undergraduate in college. A graduate student was looking for someone to support her dissertation work, which was in mother and child attachment theory. That's when, at nine months, your baby will go in anybody's arms and at 11 or 12 months, they're going to get very upset. .With that skill set, I started at Boston Children's Hospital working for a developmental psychologist name Dr. Heidelise Als as a Research Assistant. My major in college was psychology, so that's my background. She was working with premature infants. She had developed a method of caregiving for the preemies (which is very well-known now) which was tailored specifically for the sensitivity of the premature infants in the NICU.
Audrey:Behavioral caregiving is what it was called. For example, if you picture the isolette (incubator) and if you're inside of it sleeping, maybe you weigh three pounds, and you've got tubes connected to you, then someone comes along and places a bottle of formula and puts it the glass top of the isolette. What's that going to sound like to you? A thunderstorm or worse. The babies in the Brigham and Women's Hospital in Boston were admitted to one of four “pods” in the NICU. Dr. Als had the nursing staff two of the pods trained to do this behavioral caregiving and the other two didn't. And that means they're putting a blanket over the isolette to keep the light out, to keep the sound out, they are not playing radios, not talking too loudly about how their weekend was. Some of these babies are in the hospital for months and months, but fewer days on the respirator, faster weight gain and earlier discharge were evidenced by the infants that received the behavioral caregiving. I was a research assistant for her for four years and then went over to a project coordinator opportunity at the Brigham and Women's Hospital. It was managed there but it was sponsored by Bristol Myers Squibb. It was a Pravastatin Phase 3b trial to see if Pravastatin would prevent recurrent cardiac events.
Audrey:We were essentially the coordinating center. We had a couple of pretty well-known physicians leading the project, Dr. Frank Sacks and Dr. Mark Pfeffer, and we were under the oversight of Dr. Eugene Braunwald, who's kind of a legend in cardiology. We had the University of Texas Health Sciences Center doing the data management. It was like we were a CRO, but we were all academics in different parts of the country. It was a 4,200 patient, five-and-a-half-year study. After that study concluded, I looked at different opportunities, and started at a small CRO. I was a CRA there, then a lead CRA, and then a project manager for a number of years. Since then, it's just been different sponsor companies and a couple of patient recruitment companies, in many different therapeutic areas. I have been consulting for the past 10 years. Fortunately, I get to work with people that I've worked with in the past quite a bit. So, it's really nice maintaining and nurturing those connections.
ClinicalBid:It's a tight-knit community in New England, at least.
Audrey:It is. And one of the things that's critical is you don't want to burn a bridge because the person that you're…
ClinicalBid:The person you're arguing with today might be your lab buddy two years from now. Or your boss.
Audrey:Exactly. It's a very small world, especially in the Cambridge/Boston area.
ClinicalBid:Although, it's growing. With everything going on and all of a sudden in the last five or 10 years, all the money that's coming in. Let's jump back for a second, though. The study you were doing with the preemies, was that related to the drug research you talked about? Were those two separate trials?
Audrey:Those are separate things. The work with the preemies was an academic, NIH funded study with the grant writing and all the fun stuff that goes along with it like working nights and weekends for a month to get a grant application or renewal in. My foray into industry really started with Brigham and Women's. It was a half-academic, half-industry funded type of operation.
ClinicalBid:So, with the babies and the preemies, you were basically trying to emulate in the womb and outside the womb by splitting these two groups here. Did you design a protocol for that and submit it to NIH to get funding? I have so many questions. How did you get the parents to go along with that? One day somebody, you all look at each other and you go “Hmm, okay, these babies not responding well to this brightly lit, noisy environment. They're in here way too long. They should be maturing faster. Let's try to emulate the womb.” Now, you go from this concept to execution. But this was early going, this is 20 years ago, 25 years ago?
Audrey:Exactly. I haven't been to a NICU in a long time, but I hope that things are different in terms of standard of care. And we also followed those preemies as they developed, as Dr. Als was a developmental psychologist. We'd see them in the hospital and then we'd see them when they reached the point that they would have had 42 weeks of gestation had they not been premature. Then, we'd see them at nine months and 24 months and so on and so forth. I don't know if you've heard of the Brazelton scale, but it tests neurological reactions, skin tone, muscle tone, things like that in newborns – and so Dr. Als developed that developmental measuring stick for premature infants.
I was a research assistant and I was very young, but I learned how to observe them. You literally are in the NICU as a research person, so when bells and whistles go off that signal an alarm attached to the infants, I say “I can't touch that alarm or infant!” Which was awkward, but it was good. I scrubbed in, I put on a gown, and I would literally just watch, find a place on that little blank where I could find how many respirations per minute they were breathing and looking at their color and their muscle tone.
We had a control group. What's more interesting is depending on the educational and socioeconomic level of the parent, they might be eager to enroll their baby in the study more skeptical. One couple realized their baby might be enrolled in the control group and they really questioned that. They spoke to Dr. Als and then agreed to be in the study. I went through rigorous training and certification before I could evaluate the infants which was a little daunting to have so much responsibility but it was a very good experience. I miss the babies and we'd evaluate them when they'd get older and it was really neat to watch them grow up. My boss was a clinician as well as a researcher, so she would see babies and their parents in the evenings for evaluation. She did not believe in talking about a baby in front of a baby, no matter what their age was. So, I would take the baby while she spoke to the parents about her findings. So, I would walk, holding the baby, up and down the halls of the Enders Research Building while she conducted her clinics.
ClinicalBid:So, you were a stunt double for the parents of probably at least 20 babies?
Audrey:Yeah, for sure. The psychological aspect of it was very interesting because there were nurses who are all into this method and nurses who were like “Why are you telling us how to do our job?” Now, it wasn't that overt, but it was there. So, we just found nurses that supported the idea. It was a very long time ago and again, I am assuming it's standard of care by now and they must have so many other technologies. I can't even imagine.
ClinicalBid:You have to wonder. You know, so it's interesting because recently I ran into a gentleman who developed almost a disposable portable crib for preemies to be used in third world countries. So while we talk about, hopefully things have advanced and we know here in the US and other Western civilizations that we have a lot more equipment and hopefully environments that emulate the womb better and all this fun stuff — it's still a problem in third world countries. So, the research you did back then, fortunately or unfortunately, is still relevant to some places in the world that don't have Western medicine. So, it's just a fascinating subject. You wish you could go back in time and look at that again and see what was done and it would be fascinating. Some parents would say yes, some parents would say no. I can't imagine being a parent to say, “No. You're going to better emulate the womb for my child?” Not yeah, but “Hell yeah.” Versus other parents.
Audrey:Well again there was the control group that received the regular caregiving. So, if some parents would “Wait a minute, I don't want to be in the control group.”
ClinicalBid:I would be the same way. That is really interesting. That other study that you were doing, you said the first sponsored study that you did, what was that? That was about a respiratory disease?
Audrey:It was actually in cardiology, so it was the CARE study, Cholesterol and Recurrent Events, A phase 3b study. Pravastatin was on the market, but we were trying to make some potential changes or improvements to the label. Pravastatin is a statin and so it lowers your total cholesterol, your LDL. But the question was, if people are on it, do they have fewer CABGs (coronary artery bypass grafting), PTCAs (percutaneous transluminal coronary angioplasty), myocardial infarctions, transient ischemic attacks, and things like that. Could we prevent them from having as many of those? That's where I really started to learn about patient recruitment and retention because we had 80 centers, 13 of which were in Canada, and all I did all day long for five and a half years is talk to site coordinators on the phone and manage their site grant payments and manage their data entry reports. We only lost track of one patient of the 4,200 enrolled. After five and a half years the one person we could not evaluate was on the run from the FBI for impersonating a police officer. So – I did not feel so bad about that loss.
ClinicalBid:But, managed to get involved in a clinical trial. So, he lived long out there – or she – lived long enough to run from the FBI!
Audrey:So, that study was where I cut my teeth on patient recruitment because we just did it as a routine aspect of study management, and it was homegrown, grass roots efforts back then. The rules and regulations were different also. But we held an annual meeting to coincide with the American Heart Association meeting. We invited all the sites. We presented awards, just plaques and things like that for sites that were high enrollers. We did all things possible, such as having monthly calls with all the sites to share best practices. The Canadian sites enrolled very well with very high quality data. We developed a subcommittee on studying the adherence and retention rates on our study. The number one thing that became clear was that the relationship with the study coordinator is critical to patient enrollment and retention over the life of the study, because he or she listens their patients, bakes brownies for them, or goes the extra mile for their patients in small but very meaningful ways.
ClinicalBid:It's going to say roses, chocolate, pizza and Chinese food, and where do you send it? It's the coordinator. That's good to know. All right. That's the that's the focal point.
Audrey:That relationship is key. When people get upset that subjects come in and then they decide not to be in the study, I say it's a bit of marketing, it's customer service. If I went into my doctor's office and no staff looked at or greeted me for 10 minutes every single time, I'd find another doctor. That's not even for a clinical trial.
ClinicalBid:Absolutely. Clinical trials are tough, too. In the sense that you generally have patients who have an interest in what you want to do, but still some walk away and you think, “Well, wait a minute. We're doing a clinical trial on something that could potentially make your life better, but yet you still don't want to be involved.” Okay. What do you do with something like that?
Audrey:I think it’s the educational process because a lot of informed consent forms are 30 pages long. We just had someone in my respiratory study that I'm on that came in, signed informed consent. Then she went to her primary care physician and they said, “I don't think you should be in this study.” Well, I don't think she went in with the investigator brochure, the protocol, and a full safety profile on the program to date. I'm sure she went in there and said “Each day I have to put seven capsules into this thing, puncture it, and then breathe it in.” That's her understanding of what the study is “offering” her.
ClinicalBid:She didn't exactly sell it.
So, 10 years ago, fast forward now, 15 years to 10 years ago, you decided to make the leap into the ever-fun, ever-exciting world of consulting and of everything you do in terms of consulting, what part of your job is the hardest and what part of your job causes you to lose sleep and go crazy? And what part of your job is the best part of your job as an independent consultant in the space?
Audrey:I have connections with a lot of people locally and from previous companies, when I was an employee. So, I don't generally have to seek out business, but then sometimes business will come to me. Sometimes right at the start there's a diverging path (a) they don't know me, so they don't trust me, or they just don't get the consulting model, versus (b) the people that know me and we're way past that whole relationship building so I don't have to spend time trying to explain what I bring to the table or how. The hardest ones are where they are now virtual, having come from big pharma and they have not worked in this model and they get a little lost in those waters.
That frustrates them. If you are Novartis or Pfizer where you have buildings of departments of people and you can just walk over and talk to them. That is not a bad strategy and I think it's necessary in certain environments. It is not for me. I think because it is exhausting trying to justify my existence and get them to believe that I know what I'm talking about. Whereas when the trust is there, the relationship is there, and they know I'm the ClinOps expert. I have clients that have five people in the entire company. Of course, they oversee me because I'm not an employee, so I can't own certain things, but they know that I know what I'm doing. Those are the best clients, where that relationship is there, the trust is there, and then we just have similar personalities and a good sense of humor.
ClinicalBid:Excellent. In general, how many engagements do you kind of keep up in the year at once?
Audrey:Interesting. when I first started out, I went back actually to Sepracor, which is Sunovion now, because that's where I spent time as an employee doing COPD work for the Brovana product that they launched. That was a safe opportunity. It was 40 hours a week in a cubicle. Then, I started to branch out a little bit. A couple of years ago, I had five clients and I'll never do that again! One, I was working nights and weekends. Two, I couldn't keep anything straight. And three, I got to the point where I thought “I'm not doing everything as well as I should.” My motto or my mantra is “All I have is my reputation.” I don't have a brick and mortar thing. I don't make cookies. It's what I bring to the table with my expertise that is the offering. So, I saw that being over-committed as a risk.
Right now I have two and both of them are well-known to me. The trust is there and each one has client has two projects I am supporting. One was a very small phase 1b study; the other one's a phase 2b study and they may be launching another study. I have a good balance of work and life now, so I’m not over-committing myself and I am doing things well. So, I'm going to keep with two until one of them does not need me and then I'll look for something else.
ClinicalBid:The consultant's conundrum. How to deliver work and find work at the same time. But certainly, I understand what you're saying. You decided that it was better to focus on quality than quantity, and that generates a good pipeline anyway. With respect to the projects you're working on, a lot of times when I speak to people who are doing ClinOps and consulting in this space, almost always one of the questions out of my mouth is tell me about some really interesting projects you’re either working on now or once you've worked on before. Do you have any really great stories, in terms of projects that you're currently working on or worked in the past that just really you love to tell people about and tell us about them?
Audrey:When I was a consultant back at Sepracor, now Sunovion, I supported an epilepsy study and that was fascinating to me. First of all, the CRO was very good – we had seasoned professionals with a depth of knowledge about the disease area. So, at Sepracor they had a kind of a project management role and then a lead CRA role. It's not what it's called, but they mirrored internally the roles/functions they outsourced to the CRO. My equivalent to the CRO was just an amazing woman. She knew the space inside and out, would challenge lots of things in terms of study execution and the protocol. Because sponsors are very scientific and perhaps they know someone with seizures, they don't think of the things that someone who either has the disease or has worked on the disease understands.
So my lead CRA at the CRO was really great. I just learned so much from her. For example, One might have a partial seizure, which doesn't mean that the seizure stopped halfway, rather it means it effects only one part the brain. Also you might have the same classification as I do with a certain type of seizure category, but yours might manifest completely differently. It's not always the huge, grand mal seizure most people envision There are layers and definitions. We were training the sites with a video on what various seizures might look like and they showed a person, just in a restaurant, who suddenly kind of stood up and started walking around and pulling at his sweater. That was his particular seizure type at that time on that day.
People probably thought he was drunk. Now, having seen a seizure, I know what to do and what it looks like. But it's a very misunderstood disease. You cannot drive for six months or a year in most states after you report having had a seizure (or if you have been witnessed as having had one). You might have some side effects, and also there is this “postictal” state which is the altered state of consciousness after an epileptic seizure. It usually lasts between 5 and 30 minutes, but sometimes longer in the case of larger or more severe seizures, and is characterized by drowsiness, confusion, nausea, hypertension, headache or migraine, and other disorienting symptoms. Essentially, you feel “out of it.” You may not even remember everything that happened. Your physician’s may ask for details about it after the fact. You're saying “I don't know. I don't know if I even had a seizure,” and you partner or caregiver is saying “Yeah, they did.”
ClinicalBid:It's interrupting short term and long-term memory committal. It takes a while for your brain activity to settle down after the seizure.
Audrey:It's so awful to witness a seizure because you feel so helpless, but while I worked on that study, I felt really like I was doing something super important that would affect people directly. Because you can't go swimming by yourself after a seizure, and you never know when you're going to have another one. You can't drive. What if you live in the middle of nowhere? There's a lot of depression, and there's some suicidality associated with the disease.
ClinicalBid:Interesting. That sounds fascinating. I don't how they're designing a protocol for that and getting a patient population. How many sites did you have?
Audrey:I think we had about 30 sites.
ClinicalBid:You'd have to go far and wide to get a good patient population.
Audrey:Yeah, it was a global study and we did a lot of work with advocacy groups and a lot of patient recruitment or retention stuff. And then I was doing a lot of sponsor oversight, so going on site with CRAs and we had one particular CRA that I was working with. She needed some data cleaning tasks done by the study coordinator, and the coordinator was late coming back to her office. She looked really upset - - it turned out that that her patient had just had a seizure. So, it really upsets the medical staff.
ClinicalBid:Especially with the seizures. There's not much you can do other than keep them from harming themselves until a seizure passes.
Audrey:And the causes are varied. They're really, really varied. Some people are born with it. Some people get it, they just don't know why. And that's frustrating. I just found it challenging, but very, very rewarding.
ClinicalBid:Yeah. Amazing. Other than this particular study, what else pops to mind? Actually, before you go there, you bring up something that makes me think, we take the internet for granted and I worked on the internet at the national science foundation when there were five computers on it. But now I think about it, we talk about recruiting and we take it for granted. But it would be a fascinating study to correlate patient populations before and after the internet. Because when you were talking, one of the things you said is with getting a patient population that you talked about how you had the help of some of the groups that are surrounding this, and some of those groups use the internet to build populations that you can then tap into. Before the internet existed, you probably couldn't have done 30 sites.
Audrey:No, I think before the internet it was homegrown. Things are different, right? 30, 20 years ago, a lot of people just went in and did what they were told by their physicians, which isn't a bad thing and it's not a good thing. It is what it is. In fact, I'm having a call this week with a company that does patient recruitment via a database. People have databases now, so they can just search for patients. You put the ICD-9 code into their database, if they have an electronic medical record, and out pops the list of the people currently potentially eligible, or you get data from prescription databases.
I don't know if you've ever gone to CVS and they tag or print something onto your prescription bag, but it says something about a study. Those ads are sponsors paying to say, “I know this person's on levothyroxine. So perhaps I have a better option for them for their hypothyroidism. So, the internet has totally changed it. And that's good and bad. I think what happens is, again, the relationship is key. The physician and the coordinator having the relationship with and the trust of the study participant is crucial. Also, if you go out and you say, “I'm going to ask everybody on Facebook who has asthma,” you're going to get a billion responses, but how many of those are going to trickle down into being near a clinical site and wanting to be in a clinical trial? So, it's the pros and cons of the current digital age and social media that we need to weigh.
ClinicalBid:Yeah. Where now, you can go on the internet and you can go to several of the companies that are out there. We're actually talking to a number of them and you can basically tune your protocol ahead of time by going to their website and looking at the patient populations and pretty much using them like a search engine to do your protocol design based upon the patient population that you can get. And you're doing this whole thing online ahead of time, right? It's amazing what you can do to tap into it and how it's changing things. So, I wanted to ask, you had mentioned another project you've worked on related to Alzheimer's.
Audrey:Yes. That’s a client I've had for about a year now.
I don't know if you've been following the Alzheimer's space, but it's every other week, a major large pharma company loses billions of dollars because they're in late phase research and they don’t meet their endpoints. So, unfortunately, lots of us are going to have Alzheimer's and nobody wants to pay for it because they're not clear on what causes it. They’ve looked at amyloid plaque, which is something that builds up in the brain, but they're not sure. And then tau proteins and things are also being looked at. It's so slow going, but this company's been around for 10 years and they're not giving up. They just push onward and upward, day after day.
They don't want to invest in it. They don't, they want return of investment in three or six months. You have to have at least an 18-month study to see any cognitive change
ClinicalBid:Right. But the challenge there is there've been so many studies in the amyloid space that have failed. Keep chasing this amyloid issue and it's been failure after failure after failure. We've been very active on the social side of putting things out that have been written by people like the group at stat and other groups that are just saying “What are you doing? There's obviously an issue with the blood brain barrier and you're going to have to think of something new other than chasing the same process over and over and over again.”
Audrey:Some small companies obtain have fast track approval from the FDA for a smaller Phase 3 study but just can't get the funding to conduct it. When investors see failures in big pharma, they say “Well, look, a little biotech, I don't know if they can pull it off” but often the data is really compelling.
ClinicalBid:That's great. We talk a talk a lot about that. Dave and I talk about rare diseases all the time and you wonder, there are so many researchers in the world who are working in little teams, five, two, three, they're not going to get a Nobel prize. The drug has a patient population of, I'm being facetious here, one in 100,000. It's tiny. They're consumed by this research, usually because they're touched by it somehow, and they keep moving. Let's turn the page here for a second. And as we get into the tail end of our discussion which has been fascinating. Unfortunately, I think we could talk for hours about this, but let's also help our readers a little bit in terms of advice that you would give to people. You touched on it a little bit before, but you've been doing this for 25 + years and I wonder if you would give any advice to somebody either working in a CRO, working with a larger small pharma, or working as a consultant. What would you go back in time and tell yourself?
Audrey:There are a couple of things: first, never burn a bridge, which we talked about earlier. I think one thing I would change is I got very focused on ClinOps and it took me many years to understand C suite executives and managing upwards, and also market trends and competitive landscapes as the industry has evolved and continues to evolve.
In ClinOps, you're just right down in the weeds all the time. I also often tell folks to get out of your comfort zone and look at different things – but in a safe way. That's what some of the larger sponsor companies and the larger CROs are good at. People will sometimes transition over to a different business unit, which I think is neat.
The second thing was having a good, positive attitude, because I've always said I can teach someone skills, but I can't change their attitude. I have this mental four-grid block where, there’s skill set and there's attitude. Someone has a bad attitude and a good skillset, okay. If they have a bad skillset and a good attitude, okay. But if they have a bad skill set and a bad attitude, it just doesn't make sense to continue to engage that individual. I think you just have to be grateful for this career because I get calls from work every other week and it's never going to go away, clinical operations. It's just going to be there.
The last thing I would say is just being willing to adapt to change. Try to really be open to change and be sympathetic with your colleagues. A large CRO will be around for the next 50 years. We might not be around in 12 months. That’s how tight it is, so I think that just really being aware of the challenges of the senior executive team without letting it derail you is the other thing I would recommend. Try to understand the pain points and be able to manage upwards.
ClinicalBid:Right. I think it's critical as a consultant, especially if you're working with multiple customers, you're changing your laundry every day. Companies tend to, if you really develop a relationship with them, see you as an extension of their staff, which means that you have to have the ability in your mind to not just be the traditional consultant, where, I'm only going to do what's in my work order, my statement of work. I'm going to function as an extension and know that there's mutual respect. And that all ships rise here and to build that kind of relationship so that you can step in and do things that maybe you might not normally do if it was part of a statement of work, but you're doing it because it's better for the customer.
ClinicalBid:That really is the best of all worlds, if you can get yourself to the point where, as a consultant, you're basically considered to be an extension of the company you're consulting for. That's nirvana, right?
Audrey:Absolutely – that is the perfect model.
ClinicalBid:Right. To kind of work off that, if you could change anything in either the clinical research or clinical trial environment, the process itself, I'm going to give you a magic wand and you get to wave it once, maybe twice. You wave it and what happens? What changes?
Audrey:Every sponsor, every protocol gets an analysis - before they even start the study - of exactly what it's going to take to recruit and retain subjects. Do not wait until you get underway and realize you're in trouble. Because 87% of studies do not come in on time, and that fact has been known and not altered for 30 years. So, I would wave the wand and say, “Hey, I'm the chief recruitment officer and you can't do anything until we have a solid recruitment plan. How are we going to bring the patients to the study, this particular study and then how are we going to keep them in this study?” And the study cannot start until that is figured out, documented, and funded.
ClinicalBid:Interesting. You have customers or have seen people who try to kick off the trial really before you have a sense that you're going to be able to complete the trial.
Audrey:They don't know that consciously, and they must rely on the CRO. The due diligence isn't really done. And I don't think the sites are aligning with us sponsors; they're trying to estimate based on your complex protocol and its inclusion / exclusion criteria. And reality is usually not what you think. Think about it: we're in an industry that's extremely expensive and extremely unpredictable. So I'm going to buy a Lamborghini that's going to work maybe three weeks a month. I don't know what three days, but I paid a lot for it. I'm pretty happy, but I'm not happy on the days that doesn't run. That's what a clinical trial is.
ClinicalBid:Would you cut your mother's arm off to see if it grows back? That's not a good protocol.
Audrey:At the lack-of-enrollment-juncture, most sponsors panic. They add more sites, they try to motivate sites with newsletters, and then they yell at the CRO. I do really think that we have to rely on CROs. but it's a very expensive and it's very slow endeavor. That’s my frustration, watching the leadership team wring their hands and say, “Oh my gosh, we're not enrolling like we thought we would.” It’s almost always an inaccurate projection in the beginning. It's just a miscalculation that carries through the lifecycle of the study.
ClinicalBid:I won't say surprising, because you would think by now the people would have learned and maybe there's so much turnover in the industry, which you think people would have learned how to design their studies on a bell curve. Design it for an optimal enrollment and optimal path but be able to pivot and adjust fire that you can also get the data you want if it's suboptimal. If you don't get 100% of your patient population, you want inclusion and exclusion criteria to still be able to yield good results if you're down on the bell curve and you get 75% of your data and 75% of the population. It can't be an all or nothing sort of environment.
Audrey:Yeah. I think a lot of studies are powered for how many patients they need. And most sponsors will say, if we have a dropout rate of X or screen failure rate of X, they do plan for that. But even then, what is it based on? A statistician can say, I need this many PK samples to do this analysis, but that's not their job to know how many patients or countries or sites they're going to need.
ClinicalBid:Right. It's a complex thing. You have problems during execution sites not following protocols, with drugs not working the way they want. There are so many things that can go wrong over the course of a clinical trial. Even the best design is going to fail. But there's so much money piled up behind it. Even more so for a small company. You talked about a tiny company doing Alzheimer’s, their dollar is $1 million to them, versus a pharma where $1 billion is 10 cents to them.
Audrey:Right. I do think that perhaps for that reason big pharma gets it done better, but I am not sure because I haven't been in big pharma.
ClinicalBid:I don’t know. I thank God they're there, on one hand, to pay for the expensive, big research that we need. But on the other hand, you look at it sometimes and it's an odd beast. One of the reasons why we entered the marketplace here. And I also want to ask, if people want to get in touch with you, how should they reach out to you when you're done with your two current engagements?
Audrey:Contact me at
I have a website, and some of my articles under my blog. There are some articles I've written for Clinical Leader on some of this stuff. If you are bored one night and have insomnia, feel free to go on and look at that part of my web site.
ClinicalBidThank you very much for your time and I certainly look forward to having more conversations like this. Thanks again.
Audrey:Absolutely. Anytime.

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